Benefit-Risk Assessment in Drug Regulatory Decision-Making

Under FDARA 2017, FDA committed to furthering implementation of structured benefit-risk assessment into drug review

Commitments on Enhancing Benefit-Risk Assessment

  • Continue implementation of the Benefit-Risk Framework
  • Participate in stakeholder meetings
  • Draft guidance on benefit-risk assessment
  • Revise relevant MAPPs and SOPPs
  • Conduct second evaluation of Benefit-Risk Framework

Additional Opportunities to Enhance FDA’s Benefit-Risk Assessment

  • Improving accessibility for approved products
  • Use to support Advisory Committee meetings
  • Exploring additional tools to support assessment


Image credit: FDA

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